Medications Development for Drug Abuse Disorders
Information source: Johns Hopkins University
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Opioid Related Disorders; Opioid Dependence; Opioid Addiction
Intervention: Buprenorphine/naloxone (Drug); Clonidine (Drug); Tramadol ER (Drug)
Phase: Phase 1/Phase 2
Status: Recruiting
Sponsored by: Johns Hopkins University Official(s) and/or principal investigator(s): Eric C. Strain, M.D., Principal Investigator, Affiliation: Johns Hopkins University
Overall contact: Hye Han, Phone: 410-550-0490, Email: hhan9@jhu.edu
Summary
This is a study of tramadol as an agent for short-term opioid withdrawal treatment. A
randomized, double blind clinical trial comparing the efficacy and safety of tramadol to
clonidine and buprenorphine in the short-term treatment of opioid withdrawal will be
conducted. Opioid dependent participants will be treated on a residential unit. The
primary outcome measure is opioid withdrawal symptoms.
Clinical Details
Official title: Medications Development for Drug Abuse Disorders
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Primary outcome: change between groups over time in scores on a standard measure of opioid withdrawal signs and symptoms
Eligibility
Minimum age: 18 Years.
Maximum age: 60 Years.
Gender(s): Both.
Criteria:
Inclusion/Exclusion Criteria:
- Participants in this study will be males and females between the ages of 18 and 60
years.
- Applicants must be opioid dependent based upon the Structured Clinical Interview for
DSM-IV (SCID); in addition, they must have an opioid positive urine during the
screening process (or have evidence of opioid withdrawal).
- They must be healthy, with no significant medical illnesses (e. g., insulin dependent
diabetes), and without significant psychiatric illness (e. g., schizophrenia) besides
their drug dependence.
- Females will have a pregnancy test prior to study enrollment, and if found to be
pregnant will be excluded and referred to a substance abuse program for pregnant
women (the Center for Addiction and Pregnancy) on the campus.
- Volunteers will also be excluded if they have pre-admission hypotension (due to the
use of clonidine in the study).
- Applicants with a history of seizures (including substance-related seizures, such as
alcohol withdrawal related) will be excluded.
- Alcohol and/or sedative dependence will be specific exclusionary criteria (given the
small risk of seizures associated with tramadol use).
- Allergies to any of the study medications will be grounds for exclusion.
Locations and Contacts
Hye Han, Phone: 410-550-0490, Email: hhan9@jhu.edu
Johns Hopkins University (BPRU) Bayview Campus, Baltimore, Maryland 21224, United States; Recruiting Hye Han, Phone: 410-550-0490, Email: hhan9@jhu.edu Hye Han, Email: hhan9@jhu.edu Eric C. Strain, M.D., Principal Investigator David A. Tompkins, M.D., Sub-Investigator George E. Bigelow, Ph.D., Sub-Investigator Miriam Z. Mintzer, Ph.D., Sub-Investigator Kelly Dunn, Ph.D., Sub-Investigator
Additional Information
Starting date: October 2010
Last updated: April 16, 2015
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